93-Year-Old Man Implanted With Stent at NewYork-Presbyterian Hospital/Columbia University Medical Center, as Part of Ongoing Clinical Trial
Device Allows for Treatment of Complex Aortic Aneurysms, Representing a Major Advance in Vascular Surgery
Jul 7, 2008
In a New York City metro-area first, a 93-year-old Bronx man underwent implantation of a new stent graft at NewYork-Presbyterian Hospital, the only center on the Eastern Seaboard with access to this investigational device. The new stent graft was implanted under an FDA-approved clinical trial protocol. The stent graft is designed to treat a complex form of abdominal aortic aneurysms in which the weakened, enlarged vessel wall is too close to the arteries leading to the kidneys. These complex aneurysms cannot be safely treated with currently available aortic stent grafts and would otherwise require major surgery. Without treatment, patients with aortic aneurysms are at risk for sudden death.
The unique device, known as a fenestrated endograft, is a tubular, fabric graft with supporting metal stents that features custom-positioned holes (fenestrations) that ensure proper blood flow through the aorta and to the kidneys and nearby organs.
The three-hour procedure was performed under local anesthesia on July 1 at NewYork-Presbyterian Hospital/Columbia University Medical Center as part of an ongoing FDA-sanctioned clinical trial at three national sites (including NewYork-Presbyterian Hospital/Weill Cornell Medical Center). The fenestrated endograft was placed through a small incision in the groin, into the patient's arteries replacing the enlarged blood vessel and allowing for the safe passage of blood to the lower extremities.
Because every patient's anatomy is slightly different, each device, the Zenith® Fenestrated AAA Endovascular Graft by Cook Medical, is custom manufactured from a 3-D computer model based on a spiral CT scan of the patient.
Approximately 10 percent of abdominal aortic aneurysm patients have an affected area close to branching arteries for the kidneys, small bowel and liver.
"Until now, stenting these patients with a traditional endograft has been difficult or impossible. Since most of these patients are aged 70 and older, often with medical complications, open surgery is usually not an option. This new stent graft can give these patients a new lease on life," says lead surgeon Dr. James McKinsey, site chief of the Division of Vascular Surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of clinical surgery at Columbia University College of Physicians and Surgeons.
While the fenestrated endograft procedure takes more time and skill than repair of standard aneurysms, "there is not much difference for the patient, who can leave the hospital in a few days and return to normal activities in a week," says Dr. Angeliki Vouyouka, who performed the surgery alongside Dr. McKinsey. She is a vascular surgeon at NewYork-Presbyterian Hospital and assistant professor of surgery at Weill Cornell Medical College.
As with more common varieties of endovascular repair, advantages of the fenestrated endograft are expected to include less pain, fewer complications, reduced hospital stay and quicker recovery compared with open surgery.
Symptoms for abdominal aortic aneurysms may include a pulsing feeling in the abdomen, or unexplained severe pain in their abdomen or lower back.
"Often abdominal aortic aneurysms have no symptoms, so screening is very important," says Dr. McKinsey.
Any person aged 50 and older with a family history of abdominal aortic aneurysm, or anyone aged 65 and older with cardiovascular risk factors, should be screened by a vascular surgeon for the condition. Risk for abdominal aortic aneurysm increases with age, with an estimated 5 percent of men age 60 and older diagnosed with the condition.
NewYork-Presbyterian Hospital at both Columbia University Medical Center and Weill Cornell Medical Center is one of only a few sites in the U.S. that are currently approved to study the fenestrated graft. The device is already approved for general use in Canada, the European Union, Australia and New Zealand.
For more information on the clinical trial, or to refer a patient for evaluation, contact Diana Catz at 212-342-4102 at NewYork-Presbyterian/Columbia or Erin Magennis at 212-746-5949 at NewYork-Presbyterian/Weill Cornell.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million patient visits in a year, including more than 230,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report's guide to "America's Best Hospitals," ranks first on New York magazine's "Best Hospitals" survey, has the greatest number of physicians listed in New York magazine's "Best Doctors" issue, and is included among Solucient's top 15 major teaching hospitals. The Hospital's mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.